Study of Teprenone in the Treatment of Glucocorticoid-Induced Drug-Related Gastrointestinal Injury
Objective:
To evaluate the efficacy, safety, and adherence of the gastric mucosal protective agent teprenone in the treatment of glucocorticoid-induced drug-related gastrointestinal injury.
Study Design:
This study is a prospective, open-label, randomized controlled trial. The study population consists of patients with systemic lupus erythematosus requiring medium- to high-dose glucocorticoid therapy (30-60 mg/day). Eligible patients are enrolled according to inclusion and exclusion criteria and randomly assigned in a 1:1 ratio into two groups: a proton pump inhibitor (PPI) group and a mucosal protective agent group. The PPI group receives omeprazole capsules 20 mg once daily before meals, while the mucosal protective agent group receives teprenone 50 mg three times daily after meals. Both groups are treated for 12 weeks.
Primary Endpoint:
To assess the improvement in the 7-point overall symptom scale from baseline to week 12.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Huaxiang Wu
- 電話番号：0571-87783777
- メール：wuhx8855@zju.edu.cn
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18 to 70 years;
- Patients diagnosed with systemic lupus erythematosus (SLE) meeting the 2019 EULAR/ACR classification criteria for SLE;
- Receiving moderate to high doses of glucocorticoids (prednisone or its equivalent 30-60 mg , once daily);
- Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria:
- Presence of other gastric mucosal lesions, such as active ulcers, active bleeding, gastric cancer, gastric polyps, etc.;
- History of subtotal gastrectomy;
- History of endoscopic treatments, such as Endoscopic Submucosal Dissection (ESD) or Endoscopic Mucosal Resection (EMR);
- Significant psychiatric and behavioral abnormalities or mood disorders;
- History of clinically significant diseases, including: Chronic congestive heart failure (NYHA Class IV); History of echocardiography-confirmed ejection fraction (EF) < 30%; Myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within 6 months; Coronary revascularization within 6 months; Severe arrhythmia requiring treatment with Class Ia or III antiarrhythmic drugs;History of sick sinus syndrome, Mobitz II and Complete Heart Block without a permanent pacemaker implanted; QTc interval≥480 ms on screening ECG;
- Laboratory abnormalities at screening as follows: Total bilirubin > 3 times ULN (Upper Limit of Normal); AST/ALT > 3 times ULN; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m²;
- Currently receiving treatment (e.g., chemotherapy, radiotherapy, immunotherapy) for other malignancies;
- Pregnant or lactating women;
- Allergy or hypersensitivity to the study drug(s).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Proton Pump Inhibitor (PPI) group
|
Omeprazole cap 20 mg, q.d.
|
|
実験的：Mucosal protectant group
|
Teprenone 50 mg, t.i.d.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Improvement in the 7-point Global Overall Symptom Scale (GOSS) at week 12
時間枠：From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Proportion of patients with a positive fecal occult blood test
時間枠：At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
|
changes in levels of hemoglobin
時間枠：At weeks 4, 8, and 12.
|
At weeks 4, 8, and 12.
|
|
Changes in levels of fecal calprotectin
時間枠：At weeks 4, 8, and 12
|
At weeks 4, 8, and 12
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of days covered by medication
時間枠：From enrollment to the end of treatment at 12 weeks
|
The proportion of days covered is defined as the number of days with drug availability (without double-counting overlapping days) relative to the total number of days in the observation period
|
From enrollment to the end of treatment at 12 weeks
|
|
Incidence of adverse events and serious adverse events.
時間枠：From enrollment to the end of treatment at 12 weeks
|
From enrollment to the end of treatment at 12 weeks
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2026-0322
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Omeprazoleの臨床試験
-
Boehringer Ingelheim完了